13 Pellets Jobs

Key responsibilities include literature reviews, pre-formulation, pellet formulation, stability studies, process validation, technology transfer, troubleshooting, and maintaining documentation like QAQN, MFR, FPS, and logbooks. Perks and benefits Accommodation, Transportation and Mediclaim.

Role & responsibilities Granulation Supervisor Responsibilities: Supervise the granulation process, ensuring compliance with Batch Manufacturing Records (BMR) and adherence to Good Manufacturing Practices (GMP) . Ensure effective process adherence, timely production, and achievement of department goals. Focus on yield improvement , identifying and implementing strategies to optimize production efficiency and minimize waste. Monitor and maintain granulation equipment, ensuring smooth operation and troubleshooting as needed. Collaborate with cross-functional teams to address any production or quality-related issues. Provide training and mentorship to junior staff, ensuring operational efficiency and safety. Analyze production data and report on key performance indicators (KPIs) to senior management for continuous improvement. Granulation Pharmacist Responsibilities: Responsible for operating and overseeing more than two granulation machines during production, ensuring quality and quantity targets are met. Perform regular quality checks at various stages of production to maintain high-quality standards. Ensure proper machine performance, identify potential issues, and support troubleshooting and preventive maintenance activities. Ensure compliance with GMP and regulatory standards throughout the production process. Collaborate with Quality Control and Maintenance teams to resolve operational challenges and maintain machine performance. Maintain accurate production records, monitoring machine performance and production metrics. Pellets Supervisor Responsibilities: experience in pellets manufacturing in a regulated OSD pharmaceutical environment. Strong understanding of GMP, GDP, regulatory (USFDA/EU/WHO) guidelines. Good documentation, team management, and communication skills.

About Rubicon Research: Rubicon Research Limited is a fast-growing pharmaceutical formulation company dedicated to delivering value to customers and investors through the development, manufacturing, and marketing of branded specialty and generic prescription pharmaceutical products in regulated markets. With a product portfolio of over 250 SKUs across more than 70 product families, Rubicon Research has established a strong presence in the US market through its subsidiaries AdvaGen Pharma and Validus Pharmaceuticals. The company operates two US FDA-inspected R&D facilities in India and Canada, along with manufacturing facilities in Maharashtra, India, equipped with various drug development and manufacturing capabilities. Headquartered in Thane, India, Rubicon Research also maintains a sales and marketing office in New Jersey, USA. For more information, please visit www.rubicon.co.in. Position Title: Senior Executive-Formulation Development Type: Full-time Location: Thane, Maharashtra. Key Responsibilities: - Develop new products and optimize existing formulations for various dosage forms (Tablets, Capsules, Solutions, Suspensions, Pellets, MUPS) targeting regulated markets like the US, Europe, and ROW. - Conduct literature and patent searches, reviews, discussions, and documentation. - Perform API characterization, preformulation studies, and other related activities. - Plan and execute laboratory experiments on a daily basis. - Develop prototype formulas, optimize formulations and processes. - Prepare relevant documents such as MFC, BMR, STP, PDR, CPS, etc. - Collaborate with other departments including Stores, QA, RA, BD, IP sphere, CTS site, etc. - Coordinate with the Analytical Group for regular analysis of experimental samples. - Ensure effective execution of technology transfer activities at the manufacturing site. Qualifications & Pre-Requisites: - Master's in Pharmacy (Pharmaceutics). - Must-Have Skills: Formulation development experience in Solid & Liquid Oral products; experience with Pellets projects is preferred.,

Formulation - Research & Development - Pellets exp is must , Comply with GMP’s, SOP’s,regulatory documentation.,Develop Robust formulations & Evaluate patents and develop non-infringement strategiesScale up and optimization of manufacturing process.

Job Description: We are looking for an experienced Officer to join our team at our pellet manufacturing facility in Nagpur. The ideal candidate will have 4–6 years of experience in manufacturing operations.

Role & responsibilities :- Hands on experience for BMR, Process validation report, Stability Protocol, Sampling Plan, Knowledge about GDP initiation and closure of Change control, deviation in GMP. Having good knowledge of guidelines SUPAC, cGMP, Compliance, ICH Q1A,Q2,Q7, Q8,Q9, A10, Q13. Knowledge about GAP assessment between sending unit and receiving unit equipment / instrument / documents. Hands on experience with Advanced Microsoft Word, Power point and excel Effective communication and Co-ordination with CFT. Sound Scale up/down knowledge Calculation, forecasting, Risk assessment etc. Plan Lab scale experiments and perform. Preferred candidate profile :- Must Have Experience in Tech Transfer Department Documentation. M. Pharma in Pharmaceutics Proficiency in MS- Word, Excel, PowerPoint Perks and benefits :- As per Company Standard

Responsible for handling all activities pertaining to Tablets & Capsules & Pellets Mfg. Responsible to handle the team to achieve the set targets & maintain qualitative & quantitative as well as cGMP aspects. Perks and benefits Accommodation & Transportation And Mediclaim

Walk-in Interview for Zydus Lifesciences Ltd. Moraiya - Ahmedabad at Moraiya| 22nd June 2025 | We are recruiting for our Ahmedabad Units at Moraiya, Ahmedabad. Walk-in Interview Details Date : 22nd June 2025 Interview Location: Moraiya, Ahmedabad Timings: 9:00 am 3:00 pm Interview Venue: Zydus Lifesciences Limited, Moraiya Opp. Akshar industrial Park, Survey No.417,419&420, Sarkhej- Bavla N.H. No.8A, Village: Moraiya, Tal: Sanand, Dist: Ahmedabad- 382210, Gujarat, India Job Location: Ahmedabad Education Qualification: M.Sc. / M. Pharm / B. Pharm / B.sc /Diploma/ ITI Experience: 3 13 Years Production- OSD: Officer / Assistant manager : Tablet/ Capsule - Granulation, Compression, Coating, Inspection, Capsule Filling and Wurster coater. Plant Operator/ Technical Assistant : Tablet/ Capsule - Granulation, Compression, Coating, Inspection, Capsule Filling and Wurster coater. Packing: Plant operator/Technical Assistant: Blister Line(BQS), CVC Bottle Line, Sachet Packing (Wraptech) Warehouse: Officer / Sr. Executive: RM, PM, FG, Dispensing, Dispatch , Documentation Plant operator/Technical Assistant: RM, PM, Dispensing and dispatch Engineering Technician: Instrument Technician - Fitter/Electrical/Process equipments/ HVAC Operation/HVAC Validation/ Instrumentation/ Water system Quality Assurance (IPQA) Officer / Assistant Manager: IPQA in process (Mfg. and Pkg.) / QMS

Responsible for the development and dossier deliverable of genreic application for projects assigned with in the team for Europe ,Canada Australia. Preparation ,review and approval of test licenses Import license applications. Planning and procurement of RMPMs/ RLDs and inventory control at R&D for development. Preparation and review of RMPMs/Justification of Specifications/Cleaning validation report/Risk assessment report/ stability protocol/CDRs/Technology Transfer dossiers. Review of MFRs/BMRs/BPRs/PVPs/HTS, product specific questionnaire, Protocol; and report etc. for scale up and registration batches Timely and Appropriate Reponses for CMC and Bio deficiencies from regulatory agencies for filed products and review of R&D documents for regulatory and quality audits.

Role & responsibilities Review and approve product test license, Import license for RLD and API. Review and approve standard operating procedures (SOPs) of equipment, instruments & facilities. Plan and execute reverse engineering of RLD and marketed products. Conduct Pre-formulation and formulation studies to evaluate the physical and chemical properties of drug substances and drug products. Plan and optimize formulation for Injectable dosage forms. Compile, review and approve technical documents, including Formulation Development and Stability study protocol reports. Plan and perform stability studies to ensure formulation meets stability requirements. Compile, review and approve API, Formulation stability reports. Ensure compliance with regulatory documents and company quality standards. Coordinate with Analytical, Regulatory, Stores, Purchase, Project management and Development Quality Assurance teams to support product development and regulatory submissions. Maintain laboratory equipment and ensure proper calibration and maintenance. Participate in technology transfer activities to manufacturing sites. Prepare FD lab for agency audits and customer visits. Other roles and responsibilities assigned by the FD Manager and R&D Head. Preferred candidate profile Master's degree in Pharma or related field Must have 06 - 08 years of Experience in Formulation Development Must have 04 - 06 years of team handling role in R&D Centre

Role & responsibilities Prepare, review and submit regulatory documents for new drug applications, product registrations, amendments and renewals to the US, Brazil, EU, India and State Level authorities. Regulatory Submissions : Prepare and submit regulatory documents, including INDs (Investigational New Drug Applications) and NDAs (New Drug Applications) to regulatory authorities. Compliance and Licensing: Ensure compliance with regulatory requirements of US, Brazil, EU & India. Liaise with regulatory authorities for drug licensing, including product registrations, renewals and manufacturing licenses for local and international markets. Ensure timely submission of import licenses and NOcs (No Objection Certificates) for imported pharmaceutical products. Regulatory Strategy: Provide strategic input on regulatory requirements for new product development, lifecycle management and post-market activities, including regulatory intelligence gathering and competitive landscape analysis. Cross Functional Collaboration: Collaborate with R&D, Clinical, Quality, Manufacturing and Marketing teams to ensure alignment with regulatory strategies and compliance. Regulatory Health Authority Communication: Act as a liaison between the company and regulatory agencies to address questions or requests regarding regulatory fillings and approvals. Documentation and Reporting: Maintain accurate and up-to-date records of regulatory agencies submissions, communications with regulatory authorities and product approval status. Regulatory Training: Assist in training internal teams on regulatory requirements and best practices to ensure overall compliance across departments. Audit and Inspection Management: Coordinate with regulatory bodies in the event of audits, inspections or investigations. Preferred candidate profile Education: Bachelor's degree in Life Sciences (Pharmacy, Biology, Chemistry or related field). Advanced degrees (e.g. Master's or Ph.D.) are a plus. Experience: Minimum 05 -07 Years of experience in Regulatory Affairs, with a focus on regulatory submissions and drug licensing in the pharmaceutical industries. Knowledge: In-depth knowledge of regulatory requirements (FDA, EMA, ICH, etc.) drug development processes and regulatory submission strategies.

Role & responsibilities 1) Candidate should have understanding and experience in development of different types of oral dosage forms like immediate release formulation/delayed release formulations/ pellet coating and controlled release formulation,hard gelatin capsule, soft gelatin capsules, solutions, suspensions, dry powders and syrups for different Regulated and semi regulated markets. 2) Carry out pre-formulation and formulation development experiments for new chemical entities and ANDA formulations. 3) Develop new technology platforms and conduct feasibility studies for novel formulations such as microspheres, pellets, and spherules, aqueous and non-aqueous suspensions, ophthalmic and spray coated particles using various polymers. This includes preparation of prototype formulations for bio/clinical studies, analyzing experimental data and preparation of technical reports. Follow existing or prepare new SOPs and equipment operating procedures. 4) Design, develop and conduct appropriate dissolution studies for the novel dosage forms. Prepare stability protocols and collect the stability data. As per ICH guidelines, set specifications for raw materials and finished products. Organize tech transfer of developed products to plants for the manufacturing of scale up, exhibit, clinical or bio study batches. Review bio study and clinical study designs and protocols. Support clinical supply manufacturing and labeling activities along with drug supply inventory control and reconciliation. 5) Maintain inventory and reconciliation of Innovator products. Maintenance and up keeping of the lab and pilot areas. Give timely support in resolving regulatory queries. 6) Analyze and interpret significance of bio/clinical study results. Preparation and review of registration lot documents, technical reports and submission related documents in accordance with the applicable FDA and ICH guidelines such as CMC and CTD sections of IND, 505(b)2, NDA and Para III and IV certified ANDA. Interact with QC, QA, Regulatory, Marketing, Clinical, Purchasing and Commercial departments for the successful development of new products. Maintain and follow safety standards as issued by the Company.

Role & responsibilities Conduct competitive intelligence searches for understanding the competitive landscape for API pellets, granules technology and identifying opportunities for pellets business. Conduct patent searches for API pellets technology and identify blocking patents. Conduct patent infringement analysis of API pellets. Prepare report on global launch scenario for APIs through patent expiry status and regulatory exclusivity status. Tracking patent alerts for the in-house products, and studying the retrieved patents updates and communicating with R&D for feedback. Analyse customer patent queries on APIs/KSMs and draft responses to the queries.